Health and Social Care Bill

258: After Clause 57, insert the following new Clause— ““The Health Research Authority (1) There shall be a body corporate called the Health Research Authority (referred to as ““the HRA””). (2) The Secretary of State shall make all necessary regulations to establish the HRA within 12 months of the Act receiving Royal Assent. (3) The HRA shall manage a co-ordinated process for all aspects of the approval of health research involving human participants or their data, including— (a) the provision of ethics committee opinions and other approvals, (b) with the National Institute for Health Research and NHS trusts, delivering a consistent, efficient process for obtaining permission for research carried out under the scope of the Research Governance Framework for Health and Social Care (referred to as ““NHS R&D permissions””), (c) with the Medicines and Healthcare Products Regulatory Authority, improving the regulation of clinical trials of medicinal products, and (d) other such functions as may be specified in regulations including those currently being undertaken by organisations which will cease to function following the implementation of future legislation. (4) The HRA shall have the following general functions— (a) providing general oversight and guidance as it considers appropriate in relation to activities within its remit, (b) publishing annual metrics and indicators on all research approvals within its remit, (c) working with relevant bodies across England, Wales, Scotland and Northern Ireland to address differences in practice and legislation, and providing supporting guidance or codes of practice that apply across the UK, (d) superintending compliance with requirements imposed by legislation relevant to its remit, (e) monitoring developments relating to activities within its remit, and (f) facilitating and promoting health research involving human participants or their data. (5) The HRA must carry out its functions effectively, efficiently and economically. (6) In carrying out its functions, the HRA must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed). (7) The Special Health Authority known as the Health Research Agency is abolished and its functions transferred to the HRA.””